Board left hospitals in dark on its HIV product

The disclosure yesterday that a senior doctor treating haemophiliacs was unaware as late as August 1986 of safety fears concerning…

The disclosure yesterday that a senior doctor treating haemophiliacs was unaware as late as August 1986 of safety fears concerning a BTSB blood product linked to HIV infections was a shocking one; all the more so because Prof Ernest Egan learnt of the health risk only by chance.

Fourteen months after the first of seven haemophilia B patients was diagnosed with HIV, the Galway-based haemophilia regional medical director wrote to the Blood Transfusion Service Board expressing disquiet as to why he was never informed of the infections, or of the potential risks of factor 9 blood product such patients used.

In a letter to Pelican House he said he was "very disappointed" he was not told by the BTSB not to use the unheat-treated product. He had been informed by Dr Ian Temperley, medical director of the National Haemophilia Treatment Centre, that any product not heat-treated should not be used. In August 1985 the BTSB had accepted that heat treatment was essential to prevent the spread of HIV.

Dr Egan said he felt the board had a responsibility to communicate such important information to him, an assertion which Dr Emer Lawlor, the BTSB's deputy medical director, agreed with yesterday.

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The product in question was due to have been recalled in December 1985, but it became clear yesterday that many hospitals continued using it for many months. Whether it was a breakdown in communication or lack of communication is not clear. Either way, the incident illustrated a disturbingly casual approach to the issue within the BTSB.

Dr Emer Lawlor admitted yesterday that only informal contacts were made with hospitals in the initial stage and, as a result, some of them returned batches of the blood product but others did not. The first formal notice to hospitals to stop using the unheat-treated product was not issued until June 1986, almost a year after the first case of infection had been reported.

At no stage, meanwhile, was the National Drugs Advisory Board notified that there were safety fears about the locally-made factor 9. Dr Lawlor stressed there was no evidence to show that the product which should have been recalled had caused infections. But, if that was the case, it was only due to good fortune.

Evidence yesterday also revealed that the BTSB's response to the HIV threat was dramatically at odds with the expectations of Prof Temperley and the National Haemophilia Treatment Centre.

In a letter in August 1985 to the board's national director, the late Dr Jack O'Riordan, Prof Temperley expressed his disquiet at the continued use of unheat-treated factor 9. "I thought that I had made it plain that we would require all products to be heat-treated," he wrote.

He said Pelican House had had 11 months to sort out the problem, adding: "We would be failing in our duty knowing what we know now about [HIV] if we allowed anyone in the future to become infected".

The letter had been prompted by an urgent communication some days earlier to Prof Temperley from Dr Helena Daly, a locum acting on his behalf while he was on sabbatical leave.

Dr Daly said she had been speaking to Dr O'Riordan and informed him that it was now considered unethical to use any products for haemophiliacs except heat-treated ones, and that "we would want to change over completely in the near future".

Mr John Finlay SC, for the tribunal, said Dr Daly had indicated in a statement of evidence that the use of the term "unethical" was, in hindsight, not necessarily fair.

Even so, it seems clear both Dr Daly and Prof Temperley were deeply dissatisfied with the pace of action within the BTSB.

Another key document to emerge yesterday was a record of a meeting between officials from the Department of Health and the BTSB in January 1986, at which it was recommended that all blood products made before the introduction of HIV screening should be withdrawn immediately.

The BTSB first introduced such screening on October 15th, 1985. Ten days later, a regular Irish plasma donor tested positive. But, despite this, the BTSB continued to issue factor 9 made from pooled plasma for a further two months.

A patient at St James's Hospital in Dublin was found to still be using it at home as late as February 1986.